Psychoeducation/Psychoeducational Interventions

PEP Topic

Sleep-Wake Disturbances

Description

Psychoeducation or psychoeducational interventions encompass a broad range of activities that combine education and other activities, such as counseling and supportive interventions. Psychoeducational interventions may be delivered individually or in groups and may be tailored or standardized. This type of intervention generally includes providing patients with information about treatments, symptoms, resources and services, training to provide care and respond to disease related problems, and problem-solving strategies for coping with cancer. Interventions may include use of booklets, videos, audiotapes, and computers, and formats may be interactive between healthcare professionals and patients and caregivers, self-directed via use of CDs and other materials, online, or delivered telephonically. Studies using psychoeducational interventions tend to vary substantially in specific content, format, frequency, and timing of the interventions. For this reason, there is limited ability to currently examine the relative effectiveness of different formats and delivery methods. Highly specific content approaches, such as mindfulness-based stress reduction and cognitive-behavioral approaches are identified in these resources as separate interventions, rather than incorporated into overall psychoeducation.

Study Purpose:

Compare the effects of methylphenidate (MP) (psychostimulant) with those of a placebo (PL) on cancer-related fatigue. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) also was assessed.

Intervention Characteristics/Basic Study Process:

Patients with a fatigue score of greater than or equal to 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) randomly were assigned to one of the following four groups: MP plus NTI, PL plus NTI, MP plus control telephone intervention (CTI), and PL plus CTI.

Sample Characteristics:

N = 141

MEDIAN AGE = 58 years

MALES: 33%, FEMALES: 67%

KEY DISEASE CHARACTERISTICS: Diagnosis of advanced cancer

OTHER KEY SAMPLE CHARACTERISTICS: Four or above on the ESAS, normal score on the Mini Mental State Examination (MMSE), no severe comorbid conditions including severe anxiety, major depression, substance abuse, or erythropoietin use

Setting:

SITE: Multi-site

SETTING TYPE: Outpatient

LOCATION: Outpatient palliative care and oncology clinics at MD Anderson Cancer Center and at Lyndon B. Johnson General Hospital, both in Houston, TX

Conclusions:

MP, used alone or in combination with NTI, was not superior to the control group or the PL for fatigue or depression. NTI was associated with improvement in anxiety and sleep.

Limitations:

Risk of bias (no blinding)

No statistical control for multiple comparisons, which could lead to a type one error

Limited duration of two weeks

Content of CTI not described

Nursing Implications:

Although the use of MP did not prove to be effective for cancer-related fatigue, several cancer-related symptoms significantly were improved with NTI. Further research in this area would be ideal, but NTIs remain potentially effective for patient support and education and can have a positive effect on patient experience.

Intervention Characteristics/Basic Study Process:

This was an educational intervention on the side effects of radiation therapy (RT) for prostate cancer; a four-minute followed by an eight-minute tape-recorded message (informational intervention versus standard of care information) was used at treatment 1, and a different message was used at treatment 5. The outcome was the severity of the side effects from RT.

Study Purpose:

To test the effects of a psychoeducational intervention on pain, fatigue, and sleep disturbance.

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to the intervention group or the wait-list control group. The intervention consisted of a single one-on-one training session with a research nurse, which was followed by recorded guidance that provided imagery, relaxation exercises, and nature sounds. Most exercises lasted 20 minutes and were delivered via an mp3 player. The study lasted two weeks.

Sample Characteristics:

The sample was comprised of 78 patients (41% male, 59% female).

Mean age was 60.29 years (standard deviation = 11.09 years).

Patients had lung, prostate, colorectal, or gynecologic cancer.

Patients were receiving chemotherapy or radiation therapy and had multiple concurrent symptoms at baseline.

At study entry, all patients had to have fatigue, sleep disturbance, and pain scores of at least 3 on an 11-point numeric scale.

Of the patients, 71% were taking steroids, 59% were taking opioids, and 86% were taking antiemetics.

Setting:

Multisite

Outpatient

Midwestern United States

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Study Design:

The study used a randomized, controlled trial, pre- and postintervention design.

Results:

Symptom cluster scores and individual symptom scores declined in both the intervention and control groups.

The reductions in symptom cluster severity (p < 0.05), pain (p < 0.01), and fatigue (p < 0.05) were significantly greater in the intervention group than in the control group; however, the effect sizes (calculated as partial eta) were extremely small (range 0.041–0.093).

Conclusions:

The intervention demonstrated a small statistically significant effect on the symptoms of pain and fatigue and the overall symptom cluster of pain, fatigue, and sleep disturbance.

Limitations:

The study had a small sample size, with less than 100 patients.

The study had risks of bias due to no blinding and no appropriate attentional control condition.

The sample included baseline and group differences of import.

The control group had higher depression scores at baseline than did the intervention group.

A greater number of those in the intervention group dropped out of the study, suggesting that the intervention was not well accepted. Intention-to-treat analysis used the last value carried forward. If symptoms worsened, this would produce biased results.

Although the intervention was called a CBT intervention, whether cognitive reframing or problem solving was a part of the intervention was unclear. The intervention appeared to have been a relaxation or imagery therapy.

Measurement validity and reliability were questionable.

Authors used Z-scores to compare sleep disturbance severity, rather than actual scores; the reason for this was unclear. The actual change in Z-scores for this symptom was larger than the score changes associated with other symptoms, but the Z-score change was not statistically significant.

Whether average individual symptom scores were more meaningful than the total score for the cluster was unclear.

The intervention may be too expensive or impractical, in terms of training needs, to be feasible.

Nursing Implications:

The intervention was a relaxation or imagery therapy rather than a true CBT. The intervention was associated with short-term statistically significant benefits, but the actual size of the effect was small. Findings suggested that approaches using relaxation and imagery may result in some small benefit for patients, but the effect was weak.

Study Purpose:

To evaluate the feasibility of a patient-controlled, cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during treatment for advanced cancer and to assess the initial efficacy of the intervention.

Intervention Characteristics/Basic Study Process:

Patients provided baseline measures, such as measures relating to demographics and a symptom inventory, received education, and underwent training to use an mp3 player loaded with 12 cognitive-behavioral strategies (relaxation exercises, guided imagery, nature sounds). Patients used the strategies as needed for symptom management for two weeks and kept a log of symptom ratings with each use. Following the two-week intervention, patients completed a second symptom inventory and an evaluation of the intervention. Clinic staff identified patients who met the eligibility criteria based on diagnosis and treatment and then were briefly introduced to the study and asked if a research nurse could visit to provide additional information. The research nurse met with interested patients, assessed symptoms, and completed eligibility screening. Study purpose and procedures were explained, and written informed consent was obtained.

Sample Characteristics:

The sample was comprised of 30 patients (20% male, 80% female).

Mean age was 56.27 years (range 36–79).

All patients had advanced (recurrent or metastatic) cancer and were receiving chemotherapy or radiotherapy. Half of the patients had a diagnosis of gynecologic cancer. Patients had been diagnosed with lung cancer (n = 8), colorectal cancer (n = 6), and prostate cancer (n = 1).

Most patients were Caucasian, women, and had earned a bachelor’s degree or higher.

Almost all patients (n = 27) were taking two or more prescribed supportive medications to treat symptoms.

Studies were included if they included at least two of the following three symptoms: pain rated 3 or higher on a 0-to-10 scale in the previous 48 hours, fatigue in the previous week, and sleep disturbance in the previous week.

Studies were excluded if they involved postoperative or neuropathic pain.

Setting:

Multisite

Outpatient

Midwestern United States

Phase of Care and Clinical Applications:

Patients were undergoing multiple phases of care.

The study has clinical applicability for late effects and survivorship, end of life care, and palliative care.

Study Design:

The study used a one-group, pre- and postintervention design.

Measurement Instruments/Methods:

Demographic questionnaire and chart review form to record age, gender, education, race, ethnicity, cancer diagnosis, current treatments, and supportive medications prescribed, such as analgesics, steroids, psychostimulants, hypnotics, or sedatives

Symptom inventory, to measure

Pain severity, by means of four, 0-to-10 numeric rating scales for pain now, worst pain, least pain, and average pain in the last 24 hours

Fatigue severity, by means of four, 0-to-10 scales for fatigue now, worst fatigue, least fatigue, and average fatigue in the last 24 hours

Sleep disturbance, by means of a 0-to-10 scale rating sleep disturbance in the last 24 hours and, from the Pittsburgh Sleep Quality Index (PSQI), a verbal rating of sleep quality

Additional symptoms and their effects on daily functioning, as assessed by the MD Anderson Symptom Inventory (MDASI), which includes items measuring 13 common cancer-related symptoms and their effect on general activity, mood, work, relations with others, walking, and enjoyment of life

Treatment log book, in which patients tracked each time they used a cognitive-behavioral strategy. Data tracked were time of day; strategy used; and immediate pre- and posttreatment scores, on a 0-to-10 scale, regarding severity of pain, fatigue, and sleep disturbance

Poststudy evaluation, a 12-item survey created, for the current study, to assess patients’ perceptions of the acceptability of the study procedures. Among the items evaluated were time commitment; equipment; and questionnaires and factors relating to the patient-controlled, cognitive-behavioral intervention, such as length, variety, and usefulness.

Results:

Symptom scores at two weeks did not differ significantly from baseline scores; however, significant reductions in pain, fatigue, and sleep disturbance severity were found in ratings made immediately before and after the use of a cognitive-behavioral strategy.

Conclusions:

The patient-controlled, cognitive-behavioral intervention is feasible and may reduce the day-to-day severity of co-occurring pain, fatigue, and sleep disturbance.

Limitations:

The study had a small sample size, with less than 100 patients.

The study had a risk of bias due to no control group.

The study used a convenience sample comprised of well-educated, primarily female patients—a sample that may not be representative of all populations.

Uncontrolled extraneous variables, such as supportive medication use, could have influenced symptom outcomes.

Nursing Implications:

The findings support nurse education and the recommendation of the specified patient-controlled, cognitive-behavioral interventions for the management of pain, fatigue, and sleep disturbance. In regard to patient care and symptom management at all stages of cancer, nurses are the front-line educators of patients. This intervention supports the principle of autonomy for patients able to participate actively in care. Further study—a randomized, controlled trial to test the efficacy of the intervention for co-occurring pain, fatigue, and sleep disturbance—was under way at the time this study was published.

Sample Characteristics:

Of the patients, 80 were in the PMR group, 71 were in the AT group, and 78 were in the control group.

The study included a mixed sample of adults, with a mean age of 58 years, who predominantly had breast, kidney, or prostate cancer.

Setting:

Three to four weeks’ length of stay in an oncology rehabilitation clinic

Germany

Phase of Care and Clinical Applications:

Patients were undergoing the long-term follow-up phase of care.

Study Design:

The study used a quasiexperimental design, with sequential recruitment of groups and patient choice for PMR or AT.

Measurement Instruments/Methods:

Pittsburgh Sleep Quality Index (PSQI), German Translation

Results:

No statistically significant difference was found between the PMR and AT groups. Improvement was noted in the intervention groups regarding sleep latency, sleep duration, sleep efficiency, sleep medication (decreased), and daytime dysfunction.

Limitations:

Use of a validated tool validity of German translation was not addressed.

Intervention Characteristics/Basic Study Process:

The Nucare program was a short-term psychoeducational coping strategies intervention. Three delivery formats were offered: (1) small group, (2) one-to-one, and (3) a home format with didactic material. The didactic material comprised a workbook, cassette or CD containing spoken instruction to guide the individual through the workbook, and music to accompany the relaxation training component. Outcomes were quality of life (QOL) and depressive symptoms.

Sample Characteristics:

The sample was comprised of 101 patients.

Patients were included if they had head and neck primary cancer, were up to 36 months following diagnosis, had finished their cancer treatment, and were able to understand and complete the study questionnaires.

Setting:

Outpatient oncology clinic at the Jewish General Hospital Montreal, Canada

Phase of Care and Clinical Applications:

Patients were undergoing the long-term follow-up phase of care.

Study Design:

This was a feasibility study with a prospective, nonrandomized design, two groups, and repeated measures at baseline and three and four months.

Measurement Instruments/Methods:

European Organisation for Research and Treatment of Cancer Core QOL Questionnaire (EORTC QLQ-C30) to measure health-related QOL

Results:

Compared with their baseline scores, the intervention group had improved physical and social functioning, global QOL, fatigue, sleep disturbance, and depressive symptoms. The control group showed no changes in QOL or depressive symptoms.

Limitations:

The sample was a convenience one, and a significant number of people refused to participate, thereby reducing generalizibility.

Sample size was not based on any calculation or hypothesis; rather, it was determined by logistical and financial constraints, so some differences may have been missed owing to insufficient power.

Loss to follow-up was greater in the test group than in the control group.

Intervention Characteristics/Basic Study Process:

A 20-minute audiotape was used that included education about the self-care behaviors of exercise and relaxation to manage anxiety, fatigue, and sleep problems. A self-care diary mirrored the audiotape. The control group received education about side effects. Outcomes were fatigue, anxiety, and sleep.

Sample Characteristics:

The sample was comprised of 71 patients.

Mean age was 50.4 years (range 30–74).

Of the patients, 85% had stage I or II breast cancer and were receiving chemotherapy regimens with cyclophosphamide.

Setting:

Tertiary medical center and a satellite cancer treatment clinic

Southeastern United States

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

Study Design:

The study was a randomized, controlled trial.

Measurement Instruments/Methods:

A modified self-care diary measured the number of side effects, severity of each side effect, number of self-care behaviors performed for each side effect, and the effectiveness of each self-care behavior.

Results:

More women in the control group reported difficulty sleeping at baseline; both groups experienced increased severity of sleep disturbance between the first and second self-care diary.

Limitations:

Control was lacking regarding how much and what kind of information was given to women at the time of treatment. The use of the self-care audiotapes may have been insufficient.

EXCLUSION CRITERIA: Articles in which patients with cancer and cancer survivors were only a subgroup; non-English; not overtly related to sleep; intervention focused on samples of adults without cancer

Phase of Care and Clinical Applications:

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference:

The AGREE II and Cochrane Risk of Bias tool were used for evaluation of articles. Three practice guidelines and 12 RCTs were evaluated, and 27 supplemental supportive documents were reviewed (e.g., reviews, information summaries, consensus statements, best practice advice), which were not always cancer-focused. Results are summarized briefly with modest overall quality found in the practice guidelines and RCTs. Considerations were made for small samples, short follow-up in effectiveness trials, and lack of details on methods. Formal assessments were not conducted on supplemental articles to fill in missing gaps of knowledge.

Guidelines & Recommendations:

The guideline recommends, at minimum, a brief and focused assessment for sleep disturbances in patients with cancer and cancer survivors and provides options for screening tools and self-report assessments. Strategies, algorithms for screening, assessment, and management are provided based on literature, but they also are consensus-driven. The screening should include a short two-step process using standardized tools. The focused assessment then should identify chronicity and severity of the sleep problems (parameters of symptoms of poor sleep included). This includes key questions and a sleep diary for full evaluation. Referrals for noninsomnia-related disorders (e.g., apnea, restless legs syndrome) are prompted within the algorithm. Based on the initial evaluation, nonpharmacologic and pharmacologic interventions are recommended in a step process with care pathways that match the severity of the sleep disturbance (i.e., mild, transient, insomnia syndrome) with three corresponding care pathways. Preventative and supportive educational information is provided for all patients with cancer and cancer survivors that focuses on sleep hygiene and other sleep-promoting strategies. Rationale is provided for each strategy of treatment within this algorithm.

Limitations:

The guideline addresses sleep disturbances within the context of an insomnia syndrome.

All other disorders requiring referral are not within the scope of the proposed guidelines.

Menopause-related sleep disturbances are not addressed.

The use of the guideline would necessitate training of healthcare providers to fully incorporate into practice.

Nursing Implications:

A basic and focused screening for sleep problems in patients with cancer is needed, with corresponding treatment and education as pertained to the scope of practice.